Posted by Michael Wonder on 14 Dec 2020
Janssen receives positive CHMP opinion for Spravato (esketamine nasal spray) for the rapid reduction of depressive symptoms in a psychiatric emergency for patients with major depressive disorder
11 December 2020 - Positive opinion is based on results from two Phase 3 ASPIRE studies in adult patients with moderate to severe major depressive disorder with current/active suicidal ideation with intent, designed to evaluate the efficacy and safety of esketamine nasal spray used in addition to comprehensive standard of care.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the CHMP of the EMA has recommended the expanded use of Spravato (esketamine nasal spray) co-administered with oral antidepressant therapy in adults with a moderate to severe episode of major depressive disorder, as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.
